Clinical Research Risk Management


Campus & Systemwide Subject Injury Program

Campus-level and Systemwide Subject Injury Programs

Overview

Clinical Research Risk Management (CRRM) provides clinical research risk oversight within Risk Management and Insurance Services (RMIS) to help foster an institution-wide awareness of and commitment to research safety at UCSF. The objectives of the CRRM unit are to: 

  • Identify clinical research risks that pose a potentially high risk of harm to participants' safety or liability for the research enterprise;
  • Identify, develop, and promote focused outreach and safety-related educational efforts for investigators and others involved in clinical research to help reduce the risk of injury or liability;
  • Manage subject injury claims to ensure timely reporting, prompt evaluation, and fair compensation.

In partnership with the Office of Research/Institutional Review Board/Human Research Protection Program (HRPP)/Quality Improvement Unit (QIU), the Office of Ethics and Compliance, Industry Contracts, Legal Affairs, and other UCSF entities, the manager of the CRRM guides the development of best practice procedures for study investigators and other key study personnel which foster the safety and welfare of human subjects, reduce liability associated with research risk and subject injury, and enhance adherence to applicable laws, regulations, accreditation and licensure requirements.

Downloads

Phlebotomy Related Safety Alert and Advisory

Adverse Patient Reaction Procedures

To print or download copies of the Clinical Research Risk Management Program presentations created for the December 2010 Public Responsibility in Medicine and Research (PRIM&R), please click below:

Cost Benefits of an Institutionally-Based Subject Injury treatment and Management Program

To print or download copies of the Clinical Research Risk Management Program presentations created for the November 2009 Public Responsibility in Medicine and Research (PRIM&R), please click below:

Evidence-Based Clinical Research Risk Management

Cost Benefits of a Subject Injury Treatment and Management Program

Beyond Subject Injury: A Comprehensive Clinical Research Risk Management Program

For any questions relating to the Clinical Research Risk Management program, contact Nancy Jancar at 415.476.4171.